None listed
Conditions
Interventions
Single ingestion of the test food.
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Males and females aged 20-64 years. [2] Individuals who are healthy and have no chronic physical disease including skin disease. [3] Individuals whose written informed consent has been obtained after explanation of this study. [4] Individuals who can have an examination on a designated check day [5] Individuals judged appropriate for the study by the principal.
Exclusion criteria
Exclusion criteria: [1] Individuals using medical products. [2] Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. [3] Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease. [4] Individuals who are a patient or have a history of or endocrine disease. [5] Individuals with serious anemia [6] Individuals who used a drug to treat a disease in the past 1 month (except temporal usage for pollenosis). [7] Individuals whose BMI is less than 18.5kg/m2 and over 25.0kg/m2. [8] Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [9] Individuals who have and had a habit to ingest food with Citrus fruits (senshu mandarin orange, orange, lemon, navel, iyokan, bitter orange, shikuwasa), functional claims, health foods, or supplements in the past 1 month or will ingest those foods during the test period. [10] Individuals who experienced unpleasant feeling during blood drawing. [11] Individuals whose examination date is menstruation. [12] Individuals who are sensitive to the test food. [13] Individuals who excessively take alcohol (expressed in an amount of alcohol: over 30mg/day). [14] Individuals who are or are possibly, or are lactating. [15] Individuals who participated in other clinical studies in the past 1 month. [16] Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood kinetics of hesperetin (Blood hesperetin concentration, AUC(0-8h),iAUC(0-8h), Cmax, Tmax) | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary indexes Blood kinetics of hesperetin (AUC(0-inf),T1/2,MRT,Kel) * Exploratory endpoint Blood concentration of polyphenols *Safety [1] Blood pressure, pulsation. [2] Weight,body fat percentage,BMI. [3] Doctor's questions/ Adverse events. *Other indexes [1] Baseline characteristics [2] height measurement [3] Hematologic test. [4] Blood biochemical test. [5] Urine analysis. | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed